Health Canada approves TECENTRIQ® (atezolizumab) combination therapy for first-line treatment of metastatic non-squamous non-small cell lung cancer

Data show this new option can help some metastatic NSCLC patients live significantly longer¹  

MISSISSAUGA, ON, May 29, 2019 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved TECENTRIQ® (atezolizumab) in combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC), with no epithelial growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic non-squamous NSCLC.²

Lung cancer is one of the most common cancers in Canada and remains one of the leading causes of death from cancer as it is often diagnosed in the most advanced and aggressive stages of the disease.^{3, 4} NSCLC accounts for approximately 80-85% of all lung cancer cases in Canada,⁵ and is comprised of squamous cell and non-squamous carcinomas. Non-squamous lung cancer includes lung adenocarcinoma and large cell lung cancer, and makes up around 55% of all NSCLCs.⁶ The estimated five-year survival rate for patients with metastatic NSCLC is 2-13%.⁷

"Immunotherapies like TECENTRIQ represent a cornerstone in lung cancer treatment, and are crucial to providing personalized treatment approaches for many patients," says Dr. Mark Vincent, Medical Oncologist. "Clinical data support this combination as a first-line therapy that can extend survival for certain lung cancer patients."

This approval is based on results from the Phase III IMpower150 study, which showed that TECENTRIQ in combination with bevacizumab and chemotherapy (carboplatin and paclitaxel) helped people live significantly longer, compared with bevacizumab and chemotherapy alone (median overall survival [OS] was 19.2 versus 14.7 months; hazard ratio [HR] was 0.78; 95% CI: 0.64–0.96; p=0.0164) in the intention-to-treat wild-type (ITT-WT) population.⁸

"There is a high unmet need in lung cancer. The Canadian Cancer Statistics indicate that approximately half are diagnosed at stage 4, a late stage,"⁹ says Shem Singh, Executive Director, Lung Cancer Canada. "With this approval, Canadians living with NSCLC now have another first-line treatment option to fight the disease. It is important we continue to push forward additional research in lung cancer to increase survivorship and improve quality of life for patients and their families."

About the IMpower150 study¹⁰
IMpower150 is a multicentre, open-label, randomized, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with chemotherapy (carboplatin and paclitaxel) with or without bevacizumab in people with stage IV or recurrent metastatic non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. A total of 1,202 people were enrolled and randomized (1:1:1) to receive:

• TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
  
  
• TECENTRIQ and bevacizumab plus carboplatin and paclitaxel (Arm B), or
  
  
• Bevacizumab plus carboplatin and paclitaxel (Arm C, control arm)

The co-primary endpoints comparing Arms B and C were investigator-assessed OS and progression-free survival (PFS) in the ITT-WT subpopulation. Key secondary endpoints included investigator-assessed PFS, OS and safety in the ITT population.

The safety profile of the TECENTRIQ combination therapy was consistent with that observed in previous studies.¹¹  The most common adverse reactions in people receiving the TECENTRIQ combination therapy were: nausea (39.2%), fatigue (33.1%), diarrhea (32.1%), anemia (29.3%), constipation (29.8%), decreased appetite (28.8%), arthralgia (26.2%), neuropathy peripheral (23.7%), asthenia (20.6%), cough (19.6%), vomiting (18.6%), pyrexia (18.6%), neutropenia (18.6%), peripheral sensory neuropathy (16.5%), rash (16.5%), platelet count decreased (14.0%), dyspnea (13.5%), stomatitis (13.0%), hypomagnesemia (13.0%), pruritus (12.7%), neutrophil count decreased (12.2%), back pain (12.2%), hypothyroidism (11.5%), musculoskeletal pain (10.9%), and febrile neutropenia (10.2%).¹²

About the TECENTRIQ and bevacizumab combination
There is a strong scientific rationale to support the use of TECENTRIQ plus bevacizumab in combination. The TECENTRIQ and bevacizumab regimen may enhance the potential of the immune system to combat first-line advanced NSCLC.¹³ Bevacizumab, in addition to its established anti-angiogenic effects, may further enhance TECENTRIQ's ability to restore anti-cancer immunity, by inhibiting vascular endothelial growth factor (VEGF) related immunosuppression, promoting T cell tumour infiltration and enabling priming and activation of T cell responses against tumour antigens.¹⁴

TECENTRIQ is a monoclonal antibody designed to directly bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells.¹⁵ This blocks the interactions of PD-L1 with other cell-surface receptors which regulate the activation or suppression of T cells, a type of white blood cell that protects the body from infection and disease, including cancer.^{16, 17}

About Roche in immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we're investing more than ever in our effort to bring innovative treatment options that help a person's own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development program takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with the disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. In Canada, we currently have four approved medicines to treat certain kinds of lung cancer and a range of additional medicines under development to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. 

Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.

Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.

All trade-marks mentioned are the property of their respective owners.

© Copyright 2019; Hoffmann-La Roche Limited

REFERENCES
^1 TECENTRIQ (atezolizumab) Product Monograph; May 24, 2019.
^2 TECENTRIQ (atezolizumab) Product Monograph; May 24, 2019.
^3 Canadian Cancer Society. Lung Cancer Statistics. Retrieved from: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on.
^4 Lung Cancer Canada. Faces of Lung Cancer Report 2017. Retrieved from: http://www.lungcancercanada.ca/LungCancerCanada/media/Documents/Faces-of-Lung-Cancer-Report-2017.pdf.
^5 Canadian Cancer Society. Cancerous tumours of the lung. Retrieved from: http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on.
^6 American Cancer Society. What Is Non-Small Cell Lung Cancer? Retrieved from: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
^7 Canadian Cancer Society. Survival for non-small cell lung cancer. Retrieved from: http://www.cancer.ca/en/cancer-information/cancer-type/lung/prognosis-and-survival/non-small-cell-lung-cancer-survival-statistics/?region=on.
^8TECENTRIQ (atezolizumab) Product Monograph; May 24, 2019.
^9 Canadian Cancer Society. Canadian Cancer Statistics: A 2018 special report on cancer incidence by stage. Retrieved from: https://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2018-EN.pdf?la=en.
^10 TECENTRIQ (atezolizumab) Product Monograph; May 24, 2019.
^11 Socinski, M. A. et al. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. The New England Journal of Medicine. 2018; 378: 2288-2301. Retrieved from: https://www.nejm.org/doi/full/10.1056/NEJMoa1716948.
^12TECENTRIQ (atezolizumab) Product Monograph; May 24, 2019.
^13TECENTRIQ (atezolizumab) Product Monograph; May 24, 2019.
^14Socinski, M. A. et al. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. The New England Journal of Medicine. 2018; 378: 2288-2301. Retrieved from: https://www.nejm.org/doi/full/10.1056/NEJMoa1716948.
^15 TECENTRIQ (atezolizumab) Product Monograph; May 24, 2019.
^16 National Cancer Institute. T-Lymphocytes.
^17Jin, H.T. et al. Role of PD-1 in regulating T-cell immunity. Current Topics in Microbiology and Immunology. 2011; 350:17-37. Retrieved from: https://www.ncbi.nlm.nih.gov/pubmed/21061197.

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Bridget Wells, Roche Canada, T: 905-542-5072, E: [email protected]; Robbyn Walsh, Agnostic, T: 416-969-2759, E: [email protected]